This is a single center, cross-sectional study of synaptic density measurement in
patients with progressive MS as compared to RRMS and healthy controls.
Three groups of subjects will be recruited:
Subjects meeting the definition for PMS (PPMS or SPMS) by International Panel
Criteria
Subjects meeting the definition for RRMS by the International Panel Criteria,
Healthy Controls
Sample Size: We plan to enroll 40 subjects including at least 10 with PMS (PPMS or SPMS),
10 with RRMS and 10 healthy controls. This is a pilot study and the sample size
estimations are not based on power calculations. In order to attain our goal sample size
of 30 subjects, we estimate that we may need to enroll approximately 40 subjects to
account for screen failures.
Physicians at the Brigham MS Center may present the study to a subject during a regular
scheduled clinic visit. If the subject is interested in the study, a copy of the consent
form will be given. The subject will then be contacted by telephone prior to the
screening visit appointment. At the time of the subject's screening visit, an
investigator will go over the study in detail, answer any questions the subject may have
regarding the study and a licensed physician investigator will obtain informed consent.
In accordance with NIH guidelines, efforts will be made to attain a mix of study
participants, in terms of gender and racial/ethnic representation.
Subjects may be required to come for up to 4 visits for this study.
Initial Visit:
During the first visit, subjects will be administered the screening questionnaire (if
that has not already been done over telephone). Subjects will review and sign the consent
form. They will be administered standardized questionnaires for cognitive testing and/or
other co-morbidities.
PET Visit:
All subjects will undergo one visit for the PET scan. During the PET scan visits, all
women subjects of child bearing age will undergo a stat quantitative serum hCG pregnancy
test (or urine pregnancy test) and only women with a negative test will undergo the
radiopharmaceutical injection.
PET imaging procedures
For PET scanning, an intravenous (IV) catheter will be inserted into the radial
antecubital or other arm or hand vein for injection of tracer. Radiopharmaceutical will
be injected as a bolus (approximately 5mCi for [F-18]SynVest-1 followed by 5 mL of
saline).
The whole PET session will last up to 120 min.
MRI Visit:
All subjects will undergo a 3T Brain MRI during an MRI visit that may precede or follow
the PET scan visit.
Pregnancy screening prior to MRI:
All women will be queried about their pregnancy status, use of contraception and last
menstrual period. If they are reliably using contraception, can state the timing of their
last menstrual period, and do not believe they could be pregnant, we will proceed with
the MRI scan without pregnancy testing. If they cannot do this, then they will undergo a
urine pregnancy test. If a woman is seeking pregnancy and not using contraception, she
will undergo a urine pregnancy test.
MRI imaging procedures MRI scanning session will be performed at BWH MRI facility at 60
Fenwood Road, Boston, MA.
Several pulse sequences will be performed to image the brain. There will be no
intravenous contrast used for any of the MRIs.
The MRI scan session will take approximately 1 hour.
A non-diagnostic CT scan will be performed for attenuation correction of PET transmission
data at the time of initiation of scanning.
For the PET portion, as this drug is radioactive, the subject will be exposed to a small
amount of radiation as a result of participation in this study. The per unit radiation
dose for [F-18]SynVEst-1 is 1.4mSv/mCi_(37.8 μSv/MBq). The total amount of radiation
exposure from [F-18]SynVEst-1 is 7mSv (for 5mCi injected dose). This amount of radiation
is approximately 14% of the yearly amount of radiation allowed for persons who work with
radiation. Additional dose from low dose CT performed for attenuation correction of PET
images is estimated to be 1mSv per CT scan. Hence, the total radiation exposure from the
procedure is 8mSv or approximately 16% of the yearly amount of radiation exposure allowed
for persons working with radiation.
